The following data is part of a premarket notification filed by Future Impex Corp. with the FDA for Fukunda Sangyo Units Electronic Spiro.
| Device ID | K832430 |
| 510k Number | K832430 |
| Device Name: | FUKUNDA SANGYO UNITS ELECTRONIC SPIRO |
| Classification | Spirometer, Diagnostic |
| Applicant | FUTURE IMPEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-22 |
| Decision Date | 1983-09-29 |